Key Legal & Regulatory Trends in the Trillion-Dollar Healthcare Market for the New Year

If you think Obamacare is the most important story in regulation of healthcare, you're missing these key trends that will shape the medicine of 2015 and beyond. Remember that technological [...]

FTC requires mobile apps to include disclosures, adding to FDA mobile medical app regulatory requirements

The Federal Trade Commission (FTC) reports that mobile apps need to provide consumers with more disclosures, and also protect the privacy and security of consumer data--thus adding to the [...]

Tweet Your Medical Device Ad But Watch the FDA Hammer

The FDA provides guidance for pharmaceutical and medical device manufacturers as to how to present risk and benefit information for their medical devices and products on social media.

How to choose a healthcare lawyer or FDA attorney and regulatory consultant

The best way to select a healthcare lawyer or FDA attorney (or FDA regulatory consultant) for legal advice about your health and wellness service, practice, facility, or product, is to follow [...]

FDA’s evolving regulatory position on stem cell therapies

The federal appellate decision in U.S. v. Regenerative Sciences, LLC (see Court upholds FDA's legal authority to regulate stem cell therapies) also reflects FDA's evolving legal authority over [...]

Court upholds FDA’s legal authority to regulate stem cell therapies

FDA survived a legal challenge to its authority to regulate stem cells as drugs, in a landmark decision by the U.S. District Court of Appeals for the DC Circuit. FDA had cited Regenerative [...]

Stem cell laws and regulations: FDA regulation of stem cell therapies

If you wanted to upgrade the old film, "The Graduate," you'd have Dustin Hoffman's character shouting out "stem cells!" instead of "plastics!" Of course, he would immediate meet his favorite [...]

FDA issues warning letter to dietary supplement company for including cancer or diabetes in search field

The FDA issued a warning letter citing a dietary supplement company for its online content.In its warning letter to dietary supplement manufacturer M.D.R. Fitness Corp., the FDA warned that [...]

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